MASO65D (Xclair®)

PEP Topic

Radiodermatitis

Description

MAS065D is a nonsteroidal water-in-oil cream that has barrier-forming, hydrating, and anti-inflammatory properties. It contains hyaluronic acid, shea butter (emollient), glycyrrhetinic acid (licorice extract with anti-inflammatory properties), Vitis vinifera (antioxidant activity), and telmesteine (anti-elastase and anticollagen activity in vitro). It is designed to reduce anti-inflammatory reactions and maintain a moist skin environment. Xclair has been used for radiodermatitis.

Study Purpose:

To assess the efficacy of MASO65D (Xclair™) in managing radiation dermatitis (RD) during radiation therapy and the follow-up period

Intervention Characteristics/Basic Study Process:

Patients were randomized to use of MASO65D or the control cream. The control vehicle was an emollient-based cream that was similar in color and consistency but did not contain key ingredients. Patients had to observe a washout period of seven days. Patients were also instructed to apply study cream on the irradiated area three times daily, starting on first day of irradiation and continuing until three weeks after completion of radiation therapy. Patients were examined at weekly intervals during radiation therapy and three weeks after its completion.

Sample Characteristics:

The study sample was comprised of female, Caucasian patients with breast cancer.

Mean age was 57.26 years, with a range of 33.1 to 76.9 years.

All patients scored 100% on the Karnofsky Scale.

Setting:

The study took place at the European Institute of Oncology in Milan, Italy.

Study Design:

The study used a randomized double-blind vehicle-controlled design.

Measurement Instruments/Methods:

Skin toxicity was graded using the National Cancer Institute Common Termonology Criteria for Adverse Events for erythema, desquamation, edema, moist desquamation and ulceration.

Differences between arms of study were analyzed using the Mann-Whitney Test.

Itch, pain, and burning were assessed using a 0–10 cm visual analogue scale, with zero being "none" and 10 being "worst severity possible.

Results:

The study demonstrated a statistically significant difference between vehicle and MAS065D groups regarding the maximum severity of skin toxicity (p < 0.0001), symptoms of burning within the radiation field (p = 0.039), and desquamation (p = 0.02). In the MAS065D group, 13.5% reported mild-to-moderate desquamation, compared with 50% in the vehicle group. A higher proportion of the experimental group had no desquamation. The most significant differences between the two groups were recorded after three weeks of treatment. Both study creams were well tolerated for their cosmetic acceptability. No adverse events were observed or reported in either group of patients who completed the study.

Conclusions:

MAS065D had a significantly better outcome with prevention and treatment of skin reactions.

Limitations:

The study sample size was small.

A higher proportion of women with fair skin was allocated to the vehicle group, which has the potential to confounded findings.

Although five patients were withdrawn from the study, results are stated for 40 patients. It is not clear if the five cases withdrawn were eliminated from the statistical analysis.

Researchers state that results for severity of symptoms, measured with the visal analogue scale, were analyzed with Chi-square analysis or Mann-Whitney, which are not the most appropriate for integer scale data.

Study Purpose:

To assess the efficacy and tolerability of MAS065D (Xclair™) compared to a vehicle control in the management of radiation dermatitis

Intervention Characteristics/Basic Study Process:

There was a washout period of seven days for other topical medication prior to the beginning of treatment. The treatment field was divided into two sections. Participants were randomized into two groups. One received MASO65D on section one and the control vehicle on section two. The other participant group received the reverse. Participants were to apply the product three times a day upon the start of treatment and continue for two weeks after the completion of treatment.

Sample Characteristics:

N = 22 patients

MEDIAN AGE = 57 years

FEMALES: 100%

KEY DISEASE CHARACTERISTICS: Breast cancer

OTHER KEY SAMPLE CHARACTERISTICS: Total dose of 50–70 Gy over four to six weeks in daily fractions, no concurrent chemotherapy

Wilcoxon matched-pairs signed-rank test for skin grading and other measurements

Results:

Overall toxicity scale results across groups were

Grade 1: 35%

Grade 2: 35%

Grade 3: 5%

Grade 4: 0%

The mean scores for NCI grading in both treatment groups increased from visit 1 to visit 6 and then declined. With MASO65D, the mean NCI scores were lower in five of the assessment weeks; however, this difference was statistically significant only at week 4. The mean score for erythema with MAS065D was found to be significantly lower than that of the control (p = 0.031) only at visit 5. The mean score for TEWL/hydration observed in the breast sections treated with MAS065D was lower than in those treated with the control vehicle from visit 3 onward, but this was not statically significant Both the patients and investigators preferred the MAS065D (p = 0.007 and p = 0.035, respectively). The pain and itch scores were mainly 0 throughout the study, and there was no difference noted. No adverse events were reported with either skin product.

Conclusions:

MAS065D is effective in the management of radiation dermatitis, but further studies are necessary.

Limitations:

Small sample size

Total dose was 20–70 Gy (mean ± SD: 65.5 ± 13.9) over one to six weeks (5.6 ± 1.4). At the low end of dosage and short duration of treatment, skin toxicity would be expected to be lower. This factor was not discussed in the study. The authors did not describe TEWL, erythema, or skin hydration measurement sufficiently, or the manner in which the instruments provided these measures.

The way in which patient and investigator preference were measured was not clearly identified.